No registrations found.
ID
Source
Brief title
Health condition
congenital heart disease - aangeboren hartafwijking
Fontan procedure
Tetralogy of Fallot - Tetralogie van Fallot
Sponsors and support
Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting
Intervention
Outcome measures
Primary outcome
1. Aerobic fitness;
2. Cardiac functioning;
3. Daily physical activity;
4. Health related quality of life.
Secondary outcome
N/A
Background summary
A multi-centered study in the Netherlands to the effect of an exercise training program in children and adolescents (aged 12-20) who have undergone treatment for congenital heart disease (Tetralogy of Fallot and Fontan procedure) on:
1. Aerobic fitness;
2. Cardiac functioning;
3. Daily physical activity;
4. Health related quality of life.
The study has a prospective, randomized, controlled, interventional design.
Study objective
We hypothesize that exercise training will:
1. Improve aerobic fitness;
2. Will not result in adverse remodeling and/or decline of ejection fraction;
3. Will increase daily activity levels;
4. Will improve health related quality of life and psychosocial functioning.
Study design
Exercise group:
1. Baseline measurements: Within 2 months of the start of the exercise program (T0);
2. Repeated measurements: Within 2 weeks after the completion of the exercise program (T1).
Control group:
Approximately 3 months between baseline measurements and repeated measurements.
Measurements:
1. Aerobic fitness (oxygen uptake and peak power in last half minute of graded bicycle ergometer test);
2. Cardiac functioning (end-systolic and end-diastolic volume of RV and LV (Fallot group) or single ventricle (Fontan group), ejection fraction, functional reserve, NT-proBNP level);
3. Daily physical activity (percentage of day during which dynamic activities have been performed, average motility, assessed by means of an Activity Monitor);
4. Health related quality of life (assessed by TACQOL 12-15 CF and PF, SF-36 and TAAQOL-CHD);
5. Psychosocial functioning (assessed by YSR, ASR, CBCL and ABCL; STAIC, STAI-DY; SPP-A, GSES-12).
Intervention
The patients randomized to the exercise program will perform exercise training. The exercise training program will consist of 3 training sessions of 1 hour per week, for a 3-month period. Training will be aerobic at 60-70% (instead of 60%) of heart rate reserve. Standardized training will be performed group-wise under supervision of a physiotherapist at local fitness-centers. The patients randomized to the control group will continu their daily activities.
A multi-centered study in the Netherlands to the effect of an exercise training program in children and adolescents aged 10-25 instead of aged 12-20.
Inclusion criteria
1. Surgical repair for Tetralogy of Fallot through transatrial-transpulmonary repair, below the age of 2 years, or;
2. Surgical repair for single ventricle physiology, with intracardiac or extracardiac tunnel, performed before the age of 6 years as a (at least) 2-stage procedure (previous partial cavopulmonary repair);
3. At least 10 years of age;
4. Being followed in Erasmus MC, LUMC, UMC St Radboud, UMCU Wilhelmina Children's Hospital.
Exclusion criteria
1. Inability to exercise;
2. Mental retardation;
3. Standard contra-indications for MRI;
4. Ventricular outflow obstruction (peak Doppler gradient > 60 mm Hg).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2603 |
| NTR-old | NTR2731 |
| CCMO | NL25800.078.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON37291 |